DEVICE: BD SurePath (00382904905408)

Device Identifier (DI) Information

BD SurePath
490540
Not in Commercial Distribution
490540
TRIPATH IMAGING, INC.
00382904905408
GS1
August 26, 2015
1
103318015 *Terms of Use
SurePath® GYN Collection Kit contains 100 collection vials used to preserve, transport, and store cevical cytology samples.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Papanicolaou smear kit A packaged collection of instruments, equipment, and reagents required to obtain a cytology sample from the cervix and perform a Papanicolaou test (PAP). Commonly known as a Pap smear or Pap test the cells are typically smeared onto a microscope slide or mixed in a liquid fixative for microscopic examination. A Pap test is usually done as part of a woman's regular pelvic examination. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
MKQ Processor, Cervical Cytology Slide, Automated
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P970018 001
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Height: 32.5 Centimeter
Width: 31.5 Centimeter
Length: 51.5 Centimeter
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Device Record Status

6caa0185-1e58-45e6-82c0-cab781224d48
July 06, 2018
3
July 22, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
1-800-638-8663
technical_services@bd.com
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